y after one year of Herceptin use, and were given a "baseline" cardiac assessment along with regular cardiac check-ups during the study. After a median follow-up period of more than 32 months, the research team found that 49 patients (28 percent) experienced a "cardiac event." Of these, 46 patients experienced cardiac toxicity potentially associated with heart failure, and three patients experienced an asymptomatic, but significant, decrease in ventricle function. The majority of these patients (31) experienced cardiac toxicity while being treated with Herceptin alone (after prior Herceptin and chemotherapy), and the other 18 were being treated with a combination of Herceptin and chemotherapy. There was one cardiac-related death.

All but three patients improved cardiac function by discontinuing Herceptin and using such cardiac treatments as beta-blockers and ACE inhibitors. After repairing the damage, patients could then resume Herceptin treatment, Esteva says.

"The drug substantially prolongs survival, and while we found substantial cardiac toxicity, we also discovered that this side effect can be successfully treated, which was not clearly known before this study," says Esteva. "If the cardiac side effects of Herceptin treatment can be managed, the drug is safe to use."

The researchers do not know why treatment with Herceptin and/or chemotherapy can cause cardiac toxicity, but Esteva notes that some animal studies have shown that HER2 proteins play an important role in the development of cardiac cells, so the treatment may affect their normal functioning. They also cannot say whether all the toxicity seen in this study is a product of Herceptin use, given that many of the patients had prior treatment with certain chemotherapy drugs known to affect the heart, and some had other illnesses, such as diabetes, that can affect cardiac function.

Esteva stressed that advanced breast cancer patients should receive a "baseline" ca
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